Research Tool Patents: A Light At The End of the Tunnel?

In Merck KgA v. Integra Life Sciences I, Ltd., the Supreme Court held that the safe harbor under 35 U.S.C. § 271(e)(1) extended to the use of patented compounds in pre-clinical studies, provided there is a reasonable belief that the experiments would provide information relevant for submission to the F.D.A.[1] However, the Court declined to reach the question of whether infringement of so-called “research tool” patents would also fall within this safe harbor. The Federal Circuit’s recent decision in Proveris Scientific Corp. v. InnovaSystems, Inc. suggests that life sciences companies holding research tool patents need not fear that competitors may infringe them with impunity.[2]

Legal Updates & News Legal Updates Research Tool Patents: A Light At The End Of The Tunnel? December 2008 by Katie Nolan-Stevaux In Ltd., the Supreme Court held that the safe harbor under 35 U.S.C. § 271(e)(1) extended to the use of patented compounds in pre-clinical studies, provided there is a reasonable belief that the experiments would provide information relevant for submission to the F.D.A.[1] However, the Court declined to reach the question of whether infringement of so-called “research tool” patents would also fall within this safe harbor. The Federal Circuit’s recent decision in Inc. suggests that life sciences companies holding research tool patents need not fear that competitors may infringe them with impunity.[2] Research tools are reagents or methods that are useful in conducting experiments but are not diagnostic or therapeutic products or commercial scale production processes themselves. Common research tools may include cell lines, transgenic animals, particular DNA or protein sequences, libraries of chemicals, DNAs, or proteins, or even databases and software. In Proveris, the Federal Circuit was faced with the question of whether an accused infringer’s activity fell within the 271(e)(1) safe harbor where the patent at issue concerned a device to test drugs for FDA regulatory submissions. Thus, unlike in Merck, where the patented item was used as a control in experiments submitted to the FDA, Innova manufactured the patented item for others to use to obtain data for FDA submissions. Innova’s product is a research tool as it was designed to help analyze other therapeutics. In deciding Proveris, the Federal Circuit articulated a new, more stringent standard for determining when the safe harbor applies. The court anchored this standard in the relationship between the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the Hatch-Waxman Act in which the safe harbor is found. According to the Federal Circuit, the Hatch-Waxman Act aimed to correct two distortions in the FDCA: First, FDA review of drugs precluded patentees from generating profits early in the patent term. Second, because of FDA pre-market approval, the effective patent term was lengthened because competitors could only start obtaining FDA approval once the patent term was over. Section 156 of Hatch-Waxman provides for patent term extensions due regulatory delays, addressing the first distortion. Section 271(e)(1) sought to eliminate “de facto” patent term extension by immunizing competitors’ activities “reasonably related” to FDA submissions to enable competitors to prepare for market entry upon expiry of the patent. For the safe harbor provision, the key terms are “patented invention” and “reasonably related.”[3] The Supreme Court had already determined that “patented inventions” as used in Section 271(e)(1) were limited to drugs, medical devices, food additives, and color additives—i.e., substances for which FDA approval was necessary—and relied on the dual distortions of the FDCA in so ruling.[4] This definition preserves the relationship between the two sections in rectifying the distortions of the FDCA. For “reasonably related,” the Federal Circuit relied on the decision and the Federal Circuit’s 2007 opinion on remand from the Supreme Court.[5] The Supreme Court held that “reasonably related” encompassed activities where a party reasonably believed that a patented compound might work through a specific process to produce a specific result and used the compound in research that would be submitted to the FDA, if successful. On remand, the Federal Circuit concluded that preclinical activities were reasonably related to FDA submissions. Related Practices: 􀁺 Intellectual Property The Katie Nolan-Stevaux z Intellectual Property Merck KgA v. Integra Life Sciences I, However, the Court declined to reach Proveris Scientific Corp. v. InnovaSystems, First, FDA review of Merck v. Integra 5] Document hosted at http://www.jdsupra.com/post/documentViewer.aspx?fid=70be67e6-0e6d-4220-80e7-4e02faee3138In Proveris, Innova’s activities did not qualify for the safe harbor because the patent was not a patented invention under sections 156 and 271(e)(1) and because use of the patented device was never subject to FDA approval and never qualified for patent term extension. Innova’s device was not a drug, medical device, or a food or color additive. Further, it was never submitted to the FDA for approval and accordingly, the Federal Circuit found, is not eligible for safe-harbor relief. For research tool patent holders, the key question is whether research tool patents that aren’t “patented inventions” within sections 156 and 271(e)(1) may still be infringed by products that are subject to FDA approval and patent term extension. Because of the Federal Circuit’s emphasis on how the two sections (156 and 271) work together to prevent distortions caused by regulatory review, the safe bet would say that if one component is missing, then the safe harbor doesn’t exist. In order words, if the patent at issue is entitled to patent term extension, but the use of the patent is not reasonably related to FDA submissions, then the safe harbor will not apply. Similarly, if the patent is not eligible for term extension, but the accused products are submitted for FDA review, then the safe harbor should not apply either. Until this issue is actually before the Federal Circuit, life sciences companies should tread carefully during drug development. It may be a wiser approach to license a competitor’s research tools than risk a finding that the safe harbor did not apply to your drug development activities once you’ve got a product ready to launch. Footnotes [1] Ltd., 545 U.S. 193, 208 (2005). [2] Inc., --F.3d --, No. 2007-1428, 2008 WL 29671000 (Fed. Cir. Aug. 5. 2008). [3] Section 271(e)(1) provides a shield for making, using, offering to sell, or selling in the U.S. “a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.” [4] Inc., 496 U.S. 661, 672-674 (1990). [5] Ltd., 496 F.3d 1334, 1348 (Fed. Cir. 2007). Merck KGaA v. Integra Lifesciences I, Proveris Scientific Corp. v. InnovaSystems, Eli Lilly & Co. v. Medtronic, Merck KGaA v. Integra Lifesciences I, Document hosted at http://www.jdsupra.com/post/documentViewer.aspx?fid=70be67e6-0e6d-4220-80e7-4e02faee3138

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

- hide

Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.